In a majority of mastectomies, the nipple is not preserved. While breast implants are an option for women who would like to have their breasts reconstructed, nipple reconstruction is still a challenging problem which lacks good options. Currently, surgeons do their best to recreate a nipple, e.g., by cutting, folding, and suturing skin together and/or implanting the nipple area with some filler or material such as a biomaterial or some allograft. The inherent challenge is that the skin, which is taut, tends to push any additive material into the body making the nipple appear flat.
Although techniques for nipple-saving mastectomies exist, in most cases, the nipple and areola tissue are removed. There is no established gold standard procedure for nipple reconstruction, however, and with all techniques permanence of nipple projection is inconsistent or problematic, and therein is an unmet clinical need.
An example of a commercially available product that helps enlarge tissue prior to implantation of an expansion material is made by Mentor (Mentor LLC, Santa Barbara, Calif.). For breast reconstruction or augmentation, the balloon-like expander is implanted into the breast in a deflated configuration and then gradually inflated using saline to stretch and condition the breast tissue.
However, such a methodology of using an implantable, expandable balloon is not practical for nipple expansion because of the added surgical complexity in a small tissue volume, and would likely not be adopted by patients who have already gone through months of surgical progressions starting with their mastectomy.
Another example of a commercially available non-surgical, non-implanted product that helps enlarge or precondition breasts prior (for example, prior to fat grafting) is the BRAVA® (Brava, LLC, Miami, Fla.) which is typically worn at night by the user while sleeping.
However, the user is generally required to wear the device for a minimum of 10 hours per day for 10 to 14 consecutive weeks. This is usually very challenging given that a small pump must be worn in addition to the molds and a sports bra-like garment. Patient compliance is often a big challenge with BRAVA®, and further it is not intended for or capable of nipple expansion.